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Senior Executive, Regulatory Affairs at Amneal India

, , India -

Full Time

Start Date

Immediate

Expiry Date

17 Aug, 26

Salary

0.0

Posted On

19 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

ANDA Submission, Post-approval Procedures, ICH Guidelines, USFDA Guidelines, CTD Modules, Regulatory Drafting, Change Case Review, Annual Report Drafting, CBE 0, CBE 30, PAS Filing, Cross Functional Coordination

Industry

Pharmaceutical Manufacturing

Description

Description: Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to preliminary review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Drafting of the Annual Report with required submission data as per USFDA guidance. Preliminary review of entire submission package. Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions. Coordination with Cross Functional teams for the documents availability as per regulatory submission plan. Ensure the no delay in drafting and compiling the regulatory submission. Maintain regulatory information as per allocated task. Having good Regulatory CTD modules drafting & preliminary review skills.

Responsibilities

Manage ANDA submission activities and post-approval procedures in compliance with ICH and USFDA guidelines. Coordinate with cross-functional teams to draft and compile regulatory submission packages, including Annual Reports and PAS filings.